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Advertising: From 1 Different Sources

References: The Medicine’s Act, 1968. The Medicines Labelling and Advertising to the Public Regulations (SI 1978 No 41). The Medicines (Advertising) Regulations 1994 SI 1994 No 1932, and The Medicines (Monitoring of Advertising) Regulations 1994 SI No 1933.

In addition to the above, a Code of Practice for advertising herbal remedies has been agreed by the British Herbal Medicine Association in consultation with the Department of Health and the Scientific

Committee of the BHMA. It represents an act of self-discipline within the trade and profession, acceptance and observance of which is a condition of membership of the British Herbal Medicine Association. vIt is the responsibility of all placing and accepting advertisements to ensure that wording complies with statutory requirements. For any ailment or disease no claim for cure may be made.

The following extracts are few of a wide range of conditions appearing in the BHMA Code.

“The expression ‘treatment’ is not permitted except in respect of a ‘course of treatment’ by herbal medicines within the meaning of the Act.

“Advertising shall in no way induce unjustified concern that the reader is suffering from any illness, ailment or disease or that, without treatment, he may suffer more severely.

“Advertising shall not discourage the reader from seeking advice from a qualified practitioner.

“Advertising shall not invite the reader to diagnose specific medical conditions except those readily recognised by the layman and which are obvious to the sufferer. Advertising shall not use words such as: ‘magic’, ‘Miracle’, ‘Mystical’, ‘wonder remedy’, ‘nature’s remedy’, ‘break-through’ or similar terms.”

“Advertising shall not indicate medical or surgical consultation is unnecessary, or guarantee the effects of a medicine. It shall not indicate an absence of side-effects, or suggest that a product is better than or equivalent to another treatment. It shall not suggest health can be enhanced, or that health may be impaired by not taking the product. It should not be directed principally at children, or refer to recommendations by a health professional, a celebrity, etc. It shall not suggest a product is a food or cosmetic, or has a special benefit because it is ‘natural’. One cannot refer to a ‘licensed medicine’ or approved by the Dept of Health or use similar statements.” 

Health Source: Bartrams Encyclopedia of Herbal Medicine
Author: Health Encyclopedia

Medicines

Medicines are drugs made stable, palatable and acceptable for administration. In Britain, the Medicines Act 1968 controls the making, advertising and selling of substances used for ‘medicinal purposes’, which means diagnosing, preventing or treating disease, or altering a function of the body. Permission to market a medicine has to be obtained from the government through the MEDICINES CONTROL AGENCY, or from the European Commission through the European Medicines Evaluation Agency. It takes the form of a Marketing Authorisation (formerly called a Product Licence), and the uses to which the medicine can be put are laid out in the Summary of Product Characteristics (which used to be called the Product Data Sheet).

There are three main categories of licensed medicinal product. Drugs in small quantities can, if they are perceived to be safe, be licensed for general sale (GSL – general sales list), and may then be sold in any retail shop. P (pharmacy-only) medicines can be sold from a registered pharmacy by or under the supervision of a pharmacist (see PHARMACISTS); no prescription is needed. P and GSL medicines are together known as OTCs – that is, ‘over-thecounter medicines’. POM (prescription-only medicines) can only be obtained from a registered pharmacy on the prescription of a doctor or dentist. As more information is gathered on the safety of drugs, and more emphasis put on individual responsibility for health, there is a trend towards allowing drugs that were once POM to be more widely available as P medicines. Examples include HYDROCORTISONE 1 per cent cream for skin rashes, CIMETIDINE for indigestion, and ACICLOVIR for cold sores. Care is needed to avoid taking a P medicine that might alter the actions of another medicine taken with it, or that might be unsuitable for other reasons. Patients should read the patient-information lea?et, and seek the pharmacist’s advice if they have any doubt about the information. They should tell their pharmacist or doctor if the medicine results in any unexpected effects.

Potentially dangerous drugs are preparations referred to under the Misuse of Drugs Act 1971 and subsequent regulations approved in 1985. Described as CONTROLLED DRUGS, these include such preparations as COCAINE, MORPHINE, DIAMORPHINE, LSD (see LYSERGIC ACID

DIETHYLAMIDE (LSD)), PETHIDINE HYDROCHLORIDE, AMPHETAMINES, BARBITURATES and most BENZODIAZEPINES.

Naming of drugs A European Community Directive (92/27/EEC) requires the use of the Recommended International Non-proprietary Name (rINN) for medicinal substances. For most of these the British Approved Name (BAN) and rINN were identical; where the two were di?erent, the BAN has been modi?ed in line with the rINN. Doctors and other authorised subscribers are advised to write titles of drugs and preparations in full because uno?cial abbreviations may be misinterpreted. Where a drug or preparation has a non-proprietary (generic) title, this should be used in prescribing unless there is a genuine problem over the bioavailability properties of a proprietary drug and its generic equivalent.

Where proprietary – commercially registered

– names exist, they may in general be used only for products supplied by the trademark owners. Countries outside the European Union have their own regulations for the naming of medicines.

Methods of administration The ways in which drugs are given are increasingly ingenious. Most are still given by mouth; some oral preparations (‘slow release’ or ‘controlled release’ preparations) are designed to release their contents slowly into the gut, to maintain the action of the drug.

Buccal preparations are allowed to dissolve in the mouth, and sublingual ones are dissolved under the tongue. The other end of the gastrointestinal tract can also absorb drugs: suppositories inserted in the rectum can be used for their local actions – for example, as laxatives – or to allow absorption when taking the drug by mouth is di?cult or impossible – for example, during a convulsion, or when vomiting.

Small amounts of drug can be absorbed through the intact skin, and for very potent drugs like OESTROGENS (female sex hormones) or the anti-anginal drug GLYCERYL TRINITRATE, a drug-releasing ‘patch’ can be used. Drugs can be inhaled into the lungs as a ?ne powder to treat or prevent ASTHMA attacks. They can also be dispersed (‘nebulised’) as a ?ne mist which can be administered with compressed air or oxygen. Spraying a drug into the nostril, so that it can be absorbed through the lining of the nose into the bloodstream, can avoid destruction of the drug in the stomach. This route is used for a small number of drugs like antidiuretic hormone (see VASOPRESSIN).

Injection remains an important route of administering drugs both locally (for example, into joints or into the eyeball), and into the bloodstream. For this latter purpose, drugs can be given under the skin – that is, subcutaneously (s.c. – also called hypodermic injection); into muscle – intramuscularly (i.m.); or into a vein – intravenously (i.v.). Oily or crystalline preparations of drugs injected subcutaneously form a ‘depot’ from which they are absorbed only slowly into the blood. The action of drugs such as TESTOSTERONE and INSULIN can be prolonged by using such preparations, which also allow contraceptive ‘implants’ that work for some months (see CONTRACEPTION).... medicines

Over-the-counter Products

Herbal products are chiefly used to relieve symptoms of self- limiting conditions. Such products are either P (pharmacy only) or GSL (General Sales List). The Medicines (Labelling and Advertising to the Public) Regulations 1978 (SI 1978 No 41) state the range of conditions on schedule 2, parts I-IV. Dried herbs on sale under their plant or botanical name over the counter are exempt, provided no medicinal claims are made. ... over-the-counter products

British Herbal Medicine Association

Before the Medicine’s Bill proceeded to the Statute book to become the Medicine’s Act 1968, so great was the threat to the practice of herbal medicine and sale of herbal preparations, that the profession and trade were galvanised into mobilising opposition. Thus, the British Herbal Medicine Association was formed in 1964. In the ensuing struggle, important concessions were won that ensured survival.

The BHMA is recognised by the Medicines Control Agency as the official representative of the profession and the trade. Its objects are (a) to defend the right of the public to choose herbal remedies and be able to obtain them; (b) to foster research in herbal medicine and establish standards of safety which are a safeguard to the user; (c) to encourage the dissemination of knowledge about herbal remedies, and (d) do everything possible to advance the science and practice of herbal medicine, and to further recognition at all levels.

Membership is open to all interested in the future of herbal medicine, including herbal practitioners, herbal retailers, health food stores, wholesalers, importers, manufacturers, pharmacists, doctors and research workers.

The BHMA produces the British Herbal Pharmacopoeia. Its Scientific Committee is made up of senior herbal practitioners, university pharmacologists and pharmacognosists. Other publications include: BHMA Advertising Code (1978), Medicines Act Advertising guidelines (1979), the Herbal Practitioner’s Guide to the Medicine’s Act (F. Fletcher Hyde), and miscellaneous leaflets on ‘Herbs and Their Uses’.

The BHMA does not train students for examination but works in close co-operation with the National Institute of Medical Herbalists, and with the European Scientific Co-operative on Phytotherapy.

Chairmen since its inception: Frank Power, 1964-1969; Fred Fletcher-Hyde, 1969-1977; Hugh Mitchell 1977-1986; James Chappelle 1986-1990; Victor Perfitt 1990-.

During the years the association has secured important advantages for its membership, particularly continuity of sale of herbal medicines in health food shops. It continues to maintain vigilance in matterss British and European as they affect manufacturing, wholesaling, retailing, prescribing and dispensing.

See: BRITISH HERBAL PHARMACOPOEIA and BRITISH HERBAL COMPENDIUM. ... british herbal medicine association

Labelling Of Herbal Products

The law requires labels to carry a full description of all ingredients. No label should bear the name of a specific disease or promote treatment for any serious disease or condition requiring consultation with a registered medical practitioner. Labels must not contravene The Medicines (Labelling and Advertising to the Public), SI 41, Regulations, 1978.

Misleading claims and the use of such words as “organic”, “wholesome”, “natural” or “biological” cannot be accepted on product labels. The Licensing Authority treats herbal manufacturers no differently than manufacturers of allopathic products for serious conditions.

The Advertising Standards Authority does not allow quotation of any medicinal claims, except where a Product Licence (PL) has been authorised by the Licensing Authority.

All labels must include: Name of product (as on Product Licence), description of pharmaceutical form (tablet, mixture etc), Product Licence No., Batch No., quantity of each active ingredient in each unit dose in metric terms; dose and directions for use; quantity in container (in metric terms); “Keep out of reach of children” or similar warning; Name and address of Product Licence Holder; expiry date (if applicable); and any other special warnings. Also to appear: excipients, method/route of administration, special storage instructions, and precautions for disposal, if any.

Where licences are granted, the following words should appear on the label of a product: “A herbal product traditionally used for the symptomatic relief of . . .”. “If symptoms persist see your doctor.” “Not to be used in pregnancy” (where applicable). “If you think you have . . . consult a registered medical practitioner before taking this product.” “If you are already receiving medical treatment, tell your doctor that you are taking this product.” These warnings are especially necessary should symptoms persist and be the start of something more serious than a self-limiting condition.

Herbal preparations should be labelled with the additives and colourings they contain, if any. This helps practitioners avoid prescribing medicines containing them to certain patients on whom they may have an adverse reaction.

Labels of medicinal products shall comply with the Medicines (Labelling) Regulations 1976 (SI 1976 No. 1726) as amended by the Medicines (Labelling) Amendment Regulations 1977 (SI 1977 No. 996), the Medicines (Labelling) Amendment Regulations 1981 (SI 1981 No. 1791) and the Medicines (Labelling) Amendment Regulations 1985 (SI 1985 No. 1558).

Leaflets issued with proprietory medicinal products shall comply with the requirements of the Medicines (Leaflets) Regulations 1977 (SI 1977 No. 1055).

See also: ADVERTISING: CODE OF PRACTICE. BRITISH HERBAL MEDICINE ASSOCIATION. ... labelling of herbal products

Medicine’s Act, 1968. 

An enabling Act allowing subsequent definitive statutory instruments to be issued at the discretion of the Medicines Control Agency. The Act controls all aspects of the sale of medicines in the United Kingdom; with no exceptions.

Medicines fall into three categories: POM (Prescription Only Medicines), P (Pharmacy Only), and OTC (Over The Counter). POM and P medicines must be prescribed by a registered medical practitioner and dispensed by a pharmacist. P medicines can be sold only by a registered pharmacist. Health stores are concerned with the OTC products, the sale of which is governed by S.I. Medicines General Sales List, Order 1980, No 1922.

All medicines and substances used as medicine bearing a medicinal claim on label or advertising material must be licenced. Without a licence it is not lawful for any person, in his business, to manufacture, sell, supply, export, or import into the United Kingdom any medicinal products unless some exemption is provided in the Act or subsequent regulations. The prefix ML, followed by the Manufacturer’s number must appear on the label together with the product licence number prefixed by the capitals PL. For example, if any person other than a pharmacist sells a medicinal product which claims to relieve indigestion or headache, but the label of which bears no licence number, that shopkeeper (and the manufacturer) will be breaking the law.

All foods are exempt from licencing provided no claims are made of medicinal benefits.

A special licence (manufacturer’s) is required by any person who manufactures or assembles a medicinal product. (Section 8) He must hold a Product Licence for every product he manufactures unless some special exemption is provided by the Act. He may of course act to the order of the product licence holder. (Section 23)

“Manufacture” means any process carried on in the course of making a product but does not include dissolving or dispersing the product in, or diluting or mixing it with some other substance used as a vehicle for the purpose of administering it. It includes the mixture of two or more medicinal products.

“Assembly” means enclosing a medicinal product in a container which is labelled before the product is sold or supplied, or, where the product is already enclosed in a container in which it is supplied, labelling the container before the product is sold or supplied in it. (Section 132)

From the practitioner’s point of view, herbal medicines are exempt from the Act and no licence is required.

The consulting herbalist in private practice who compounds his own preparations from medicinal substances may apply to the Medicines Control Agency, 1 Nine Elms Lane, London SW8 5NQ for a manufacturer’s licence to authorise mixture and assembly, for administration to their patients after he has been requested in their presence to use his own judgement as to treatment required. Products thus sold, will be without any written recommendation and not advertised in any way.

The “assembly” aspect of his licence refers to his ability to buy in bulk, repackage and label. Where he uses prepackaged products and does not open the packet, or relabel, a licence is not required. He will not be able to use terms, “Stomach mixture”, “Nerve mixture”, etc, implying cure of a specific condition.

It is necessary for the practitioner to have a personal consultation with his patient before making his prescription. Subsequent treatment may be supplied by a third person or by post at the discretion of the practitioner.

A licence is required where one or more non-herbal ingredients (such as potassium iodide, sodium citrate, etc) are included. Dispensing non-herbal remedies constitutes “manufacture” for which a licence is required. (MAL 24 (3))

The main thing the licensing authority looks for before granting a licence is evidence of safety. The manufacturers’ premises must be licenced. A wholesaler or distributor, also, must have a licence.

Where a product is covered by a Product Licence certain medicinal claims may be made. Where claims are made, the Act requires a warning to appear on the label worded: “If you think you have the disease to which this product refers, consult a registered medical practitioner before taking this product. If you are already receiving medical treatment, tell your doctor you are also taking this product.” (SI 41, s.5)

Labels of all medicines, tablets, etc, must carry the words: “Keep out of the reach of children”.

Under the Act it is illegal for medicines to be offered for sale for cancer, diabetes, epilepsy, glaucoma, kidney disease, locomotor ataxy, paralysis, sexually transmitted diseases and tuberculosis; these diseases to be treated by a registered medical practitioner only.

Definition of a herbal remedy. A “herbal remedy” is a medicinal product consisting of a substance produced by subjecting a plant or plants to drying, crushing or any other process, or of a mixture whose sole ingredients are two or more substances so produced, or of a mixture whose sole ingredients are one or more substances so produced and water or some other inert substances. (Section 132)

No licence is required for the sale, supply, manufacture or assembly of any such herbal remedy in the course of a business in which the person carrying on the business sells or supplies the remedy for administration to a particular person after being requested by or on behalf of that person, and in that person’s presence, to use his own judgement as to the treatment required. The person carrying on the business must be the occupier of the premises where the manufacture or assembly takes place and must be able to close them so as to exclude the public. (Section 12 (1))

No licence is required for the sale, supply, manufacture or assembly of those herbal remedies where the process to which the plant or plants are subjected consists only of drying, crushing or comminuting and the remedy is sold or supplied under a designation which only specifies the plant or plants and the process and does not apply any other name to the remedy; and without any written recommendation (whether by means of a labelled container or package or a leaflet or in any other way) as to the use of the remedy. (Section 12 (2)) This exemption does not apply to imported products. Except where a herbal product is supplied for a medicinal use, legally it is not even a medicinal product.

The 1968 Act has been a great step forward in the history of herbal medicine, The British Herbal Medicine Association and the National Institute of Medical Herbalists fought and won many special concessions. In years following the Act standards rose sharply. Practitioners enjoy a measure of recognition, with power to manufacture and dispense their own medicines and issue official certificates for incapacitation for work.

See: BRITISH HERBAL MEDICINE ASSOCIATION. NATIONAL INSTITUTE OF MEDICAL HERBALISTS. ... medicine’s act, 1968. 


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